FDA Reverses Avastin Approval as Breast Cancer Treatment

Washington - The Food and Drug Administration (FDA) said Friday it is removing the approval of Roche Holding's drug Avastin as a breast cancer treatment because it isn't safe and effective for that type of cancer.

Avastin's approval for treatment of other types of cancers are not affected. The drug will remain approved as a treatment for certain types of colon, lung, kidney and brain cancer.

But for breast cancer, the agency said there was no evidence that Avastin provides a benefit in terms of allowing women to live longer or improving their quality of life. Analysts have estimated cutting the breast-cancer indication could slice $1 billion off of the drug's $6 billion-plus annual sales.

"After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks," said FDA Commissioner Margaret Hamburg, who made the final decision about Avastin. The agency noted that the drug has a risk of severe bleeding, heart attacks and heart failure.

Because the drug is already on the market for other cancers, however, doctors could still use the product as a breast cancer treatment but Roche won't be allowed to market it for that use in the US.

Avastin was approved for metastatic breast cancer, or cancer that spread beyond the breast in February 2008 for use in combination with a chemotherapy drug, under the FDA's accelerated approval program. That program is a type of temporary approval to allow products that treat life-threatening conditions to be approved with less clinical data than typically required. Companies are required to keep studying drugs and then submit the data for regular or full approval, which Roche's Genentech unit did.

The company submitted two studies, which the FDA said showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone -- not enough to outweigh the risk of taking the drug.

Roche's Genentech unit said in a statement that it was disappointed with the decision. The company said it would start a study of Avastin in combination with the chemotherapy drug paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin.